adthera bio’s Post

🔬 In-House vs. CDMO Manufacturing for Cell & Gene Therapies: Making Strategic Choices 🔬 As cell and gene therapies gain momentum, companies face the challenging decision of producing therapies in-house or partnering with Contract Development and Manufacturing Organizations (CDMOs). Each option has critical trade-offs affecting quality, flexibility, cost, and scalability. 🏭 In-House Production offers full control over quality and flexibility to innovate, particularly beneficial for personalized treatments. Companies can secure intellectual property, refine protocols, and adapt processes as science evolves. However, it demands substantial capital, operational expertise, and long-term commitment to regulatory compliance. 🤝 CDMO Partnerships provide a fast, lower-risk path to market, ideal for startups or companies with limited manufacturing expertise. CDMOs manage GMP-compliant facilities and workforce training, facilitating speedier regulatory navigation and allowing innovators to focus on R&D. Yet, risks include dependency on external scheduling and potential Intellectual Property (IP) challenges. 🔄 Hybrid Models are becoming popular, allowing companies to leverage CDMOs in early phases and gradually bring capabilities in-house to support commercial scaling. This hybrid approach balances control and speed, addressing resource constraints and aligning production to long-term growth. 💡 Key Considerations in the Decision-Making Process: 💰 Cost and Capital Investment: In-house facilities demand higher upfront costs, but CDMOs can offset early investment, reducing financial strain. 🎢 Product Complexity and Customization: Tailored therapies may benefit from in-house control to manage detailed manufacturing needs. 🚀 Speed to Market: CDMO partnerships can accelerate timelines, while in-house production may slow clinical entry but offer smoother scaling later. ✔ ❌ Regulatory Landscape: CDMOs often bring established regulatory expertise that in-house setups may require time to build. This pivotal decision affects every aspect of therapy development, from IP control and regulatory oversight to cost-efficiency and long-term adaptability. 💯 What strategic choices are you making in your cell and gene therapy journey? 📝 Source and interesting insights in comments. 👇 #CellTherapy #GeneTherapy #ATMP #Biomanufacturing #CDMO #InHouseManufacturing #LifeSciences

Call for Abstracts (Deadline: 21st October 2024) With my conference co-chairs Nelly Montenay and Alex DiBenedetto, I am pleased to announce that oral abstract submissions are extended for the ECI Single Use Technologies VII: Revolutionizing Manufacturing for Tomorrow’s Medicines. I share my passion with ensuring the quality and sustainability of supply of single-use technologies for medicines manufacture with my co-chairs. Alex DiBenedetto further shares his views: "Single-use technologies (SUTs) are revolutionizing the biomanufacturing landscape. Production facilities are becoming smaller, faster, and more efficient. Newer applications like continuous manufacturing and process intensification have necessitated advancements including flexible bioreactors for rapid scale-up, disposable chromatography columns for efficient purification, and integrated platforms combining multiple systems/instruments in a single unit. These advancements are driving biotherapeutic innovation and development speed in fields like cell therapy, gene therapy, and vaccine production." You can find out more about the conference on the website (link in the comment section.   Don’t forget to sign up for the mailing list to receive the most up to date information.

𝘍𝘳𝘰𝘮 𝘢 𝘤𝘦𝘭𝘭 𝘵𝘰 𝘢 𝘭𝘪𝘧𝘦-𝘴𝘢𝘷𝘪𝘯𝘨 𝘵𝘩𝘦𝘳𝘢𝘱𝘺.  𝗣𝗮𝗿𝘁 𝟰: 𝗧𝗵𝗲 𝗰𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 𝗼𝗳 𝗮𝗰𝗰𝗲𝘀𝘀𝗶𝗯𝗶𝗹𝗶𝘁𝘆 𝗮𝗻𝗱 #𝘀𝗰𝗮𝗹𝗮𝗯𝗶𝗹𝗶𝘁𝘆 𝗶𝗻 𝘁𝗵𝗲 𝗽𝗿𝗼𝗱𝘂𝗰𝘁𝗶𝗼𝗻 𝗼𝗳 #𝗯𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝘀 𝗮𝗻𝗱 𝗰𝗲𝗹𝗹 𝘁𝗵𝗲𝗿𝗮𝗽𝗶𝗲𝘀    Despite the tremendous therapeutic potential of Biological and Cell & Gene Therapies therapies, significant challenges remain that limit their accessibility and scalability. One of the main obstacles is the high cost associated with developing and producing these therapies, which can hinder their widespread adoption and limit patient access.    Additionally, the complexity of #biomanufacturing processes and the need to meet rigorous quality and safety standards may further increase costs and delay the commercialization of these therapies. This can be especially problematic for personalized therapies that require individualized manufacturing for each patient. Another major challenge is the limited production capacity and lack of adequate infrastructure to manufacture biological and cell therapies on a large scale. This can hinder the ability to meet the growing demand for these treatments and limit their availability to those who need them. To address these challenges, a collaborative approach involving all stakeholders is needed, as investments in research and development, and incentives to promote innovation and efficient manufacturing of large-scale biological and cell therapies. The limitation in the current installed biomanufacturing capacity requires rethinking how we produce today so that the discoveries that appear at an increasingly accelerated rate can be produced in a manner sufficient to cover the also growing needs of the population.   Solutions with higher efficiency like microfluidics approaches can bring benefits in terms of productivity, costs and footprint, while also involving sustainability improvements to the manufacturing process. Being able to scale those flexible technologies to commercial scale is shifting the way biomanufacturing is being done. Companies that are starting to adopt these technologies for their projects will have a great advantage when thinking in launching new therapies or expanding their facilities. That way, solving the limitation in the current installed biomanufacturing capacity with innovative approaches will impact not only the industry by better costs for manufacturers but also lead to better treatment access for patients. Let me know if you find any other difficulties in biomanufacturing! #biologics #atmp #advancedtherapies #CGT #biotech #pharma

🌐 We’re Live! adthera’s New Website is Here 🌐 We’re excited to announce the launch of adthera’s brand-new website, designed with a digital-first approach to showcase our cutting-edge solutions in cell and gene therapy manufacturing. At adthera, we’re committed to empowering innovation and driving outstanding outcomes, and our new website reflects this. With nearly 50 entries in our Resource Section, you'll find valuable insights, whitepapers, and case studies that highlight our expertise and demonstrate how we’re helping accelerate process development and scale life-saving therapies. Explore how adthera is reshaping the future of cell therapy with tailored solutions that support your journey from process development through to manufacturing—all while ensuring the highest standards of safety, quality, and cost-efficiency. 💡 What you’ll discover on our new website: -Our digital-first approach to process development -Insights into our commitment to innovation and quality -A robust resource section with nearly 50 entries 📲 Visit us now at www.adthera.bio to explore our new platform and access the resources that will help you advance your cell therapy innovations. 🚀 Follow our LinkedIn page to stay updated on our latest innovations and resources #cdmo #regenerativemedicine #digitalfirst #celltherapy #immunotherapy #innovation #processdevelopment #continousimprovement #gmp #clinicaltrials #atmp #advancedtherapies #personalizedmedicine #gxp #optimization #automation #bestinclass #rightfirsttime #celltherapymanufacturing #innovation #digital #partnerships #collaboration #networking #digitaltransformation #quailtycontrol #qualityassurance #GMP #simulation #manufacturing #processdevelopment

When innovation and collaboration are at their highest, patients always benefit. And at DKP, we are all about the patient. As a trusted thought partner for manufacturers, we navigate the complexities of market access to ensure groundbreaking therapies reach the patients who need them most. We’re encouraged by the FDA’s recent draft guidance around enhancing the development of platform technologies for expediting cell and gene therapy approvals. Expected impacts include: - Leveraging Existing Data: Allows biopharma companies to use existing data to potentially eliminate the need for product-specific assessments. - Support for Innovation: Encourages leveraging platform technologies to expedite product development. - Streamlined Pathway: Defines platform technology and sets specific criteria to streamline drug development and manufacturing. The draft guidance is part of ongoing efforts to support the efficient development and approval of cutting-edge technologies that address multiple healthcare needs. DKP has been committed to getting new and novel therapies into the hands of patients for nearly 25 years. As always, we're here to support your efforts to bring life-changing treatments to market more swiftly and efficiently. #FDA #CellTherapy #GeneTherapy #cgt #cellandgenetherapy

🚀 This year, life sciences embark on a transformative journey of digital innovation. Navigating this landscape demands foresight and agility as companies tackle complex regulatory frameworks and unpredictable market conditions. Here are the top 5 trends observed in life sciences this year: 1️⃣ Mergers and Acquisitions: A strategy for diversification and growth, reflecting the industry's shift towards consolidating resources and expertise. 2️⃣ Innovative Therapies: Heavy investment in developing 'blockbuster' medicines and next-gen treatments like cell and gene therapies. 3️⃣ Digital Health Integration: Revolutionizing the industry with personalized and data-driven healthcare solutions. Stay tuned for more exciting trends in life sciences! https://lnkd.in/gsKYEEyd #LifeSciences #DigitalInnovation #Healthcare

When we talk about gene and cell therapies, we usually discuss what the end product will treat rather than the manufacturing process. But one part of that process could be a huge factor in future development; the possibility of bringing manufacturing closer to where the product is needed. Tom Lynch talks about the possibilities of decentralized manufacturing in his latest blog post. https://lnkd.in/gHxkr-8h

It's been over a decade since the buzz about using cell and gene therapy to treat rare diseases and advanced cancers began. Yet, the CMC aspect of cell and gene therapy remains challenging and costly. As a cell and molecular biologist with almost two decades of experience, I understand the complexity of working with living cells or genetic material. Strict guidelines and requirements from regulatory agencies demand extensive documentation, testing, and validation efforts to ensure patient safety and product efficacy. Developing new cell and gene therapy products involves significant research, preclinical studies, process optimization, and clinical trials—all requiring substantial financial investment. To tackle these challenges and curb costs, companies often turn to quality control and validation firms specializing in cell and gene therapy. By partnering with these firms, companies can streamline their manufacturing processes, optimize resource utilization, and ultimately reduce costs while maintaining product quality and regulatory compliance. Let's connect and explore how we can tailor solutions in reducing the cost at the CMC part of Cell and Gene therapy! 🚀 #CellTherapy #GeneTherapy #QualityControl #ValidationFirms #CMC #Biotech #Pharma #RegulatoryCompliance #Optimization #Success

You have probably heard about Quality by Design (QbD), but what does it mean in the context of cell and gene therapies? QbD transcends traditional development by focusing on scientific and risk-based frameworks. It enables a more systematic and precise development process for CGTs. By integrating QbD, you can achieve compliance with stringent regulatory requirements, mitigate variability, and elevate the overall quality of your therapeutic products. This proactive strategy embeds quality deep within the process, reducing reliance on extensive end-product testing and saving critical time and resources. Embracing QbD in CGT ensures regulatory excellence and structures the production process for complex therapies from the ground up. It provides deep insights into critical process parameters and quality attributes specific to CGTs, optimizing quality control and minimizing the need for extensive testing. By proactively identifying and controlling variations, QbD reduces potential failures in clinical application and sets a new standard in therapy development. Interested in deepening your process knowledge with QbD? Connect with our experts today. https://lnkd.in/ek99uMB4 #qualitybydesign #celltherapy #genetherapy #cdmo